NCT05632679

Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults

Effects of a Personalized Sound Intervention on Anxiety, Pain, and Satisfaction During Autogenous Gingival Graft in Adults: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Université de Montréal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Anxiety feeds the avoidance of dental treatments, leading to the neglect of general oral health. This avoidance is often amplified by the fear of potential pain and dissatisfaction after a dental appointment. A music listening intervention could be beneficial to reduce anxiety, pain and dissatisfaction. This intervention has the advantage to be non-invasive, cheap, and easy to implement in clinical settings. The objective of this study is to explore the effects of a personalised musical intervention on anxiety, pain and dissatisfaction associated with an autogenous gingival graft in comparison to the use of an audiobook (control). In this regard, three groups of patients will receive the gingival graft along with the personalized music intervention (n=20), an audiobook (n=20) or standard care (n=20). Participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition). However, since the third standard care control group was added as of 07-01-2023, all recruited participants will be enrolled in the standard care control group (non-randomized). Self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up).

Conditions

• Music Intervention
• Gingival Graft
• Anxiety
• Pain
• Dissatisfaction

Interventions

Type	Name	Description
OTHER	personalized music intervention	participants who are randomly selected to this group will choose three set of music they prefer among the available selection of instrumental music in the application
OTHER	selected audio book	participants who are randomly selected to this group will choose one audio book they prefer among the available selection of audio books on the tablet

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-11-30
• Last updated: 2023-07-05

Locations

3 sites across 1 country: Canada